'Smart Reminder': a Randomized Controlled Trial on the Effect of a Wearable Device

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Sham device

Wearable device -'Smart Reminder'

Clinical Study ID

NCT05877183

Smart reminder

Ages > 18
All Genders

Study Summary

Using wearable devices in the home setting allows continuous remote monitoring and feedback for intense self-directed training, an effective alternative to in-person rehabilitation. Emerging literature demonstrated that wearable devices are promising tools to enhance and deliver home-based upper limb training in stroke survivors. Nevertheless, previous reviews (Wang et al., 2017; Rodgers et al., 2019) highlighted a paucity of high-quality evidence concerning the clinical application of wearable devices in home-based rehabilitation.

This study examines the effectiveness of the enhanced version of the wearable device as a home-based upper limb rehabilitation intervention to improve the hemiplegic upper limb motor function of persons with stroke. The study seeks to address the research question:

'Is wearable device intervention in the home more effective in promoting arm recovery in stroke survivors than conventional therapy with a sham device after treatment and follow-up?' We hypothesize that the multimodal feedback system and improved features from the wearable device will provide a more effective and sustainable treatment option than conventional therapy with a sham device to promote the motor recovery of the hemiplegic UL function in persons with stroke.

A parallel single-blinded randomized controlled trial will be conducted in Hong Kong hospital outpatient and/or community stroke service settings. There will be two study groups: (1) a wearable device group and (2) a sham group. Forty participants will be randomly allocated into any of the two study groups (1) the experimental (wearable device) group and (2) the sham group (use the pictorial handout and sham device) using a computer-generated random number sequence to conceal the allocation.

Participants in the experimental group will undergo a 4-week wearable device treatment and participants in the sham group will receive a sham device and complete a 4-week conventional training. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, and follow-up at 8-week by blinded assessors.

The results of this study will show the possible efficacy of the wristwatch device in promoting motor recovery of the hemiplegic upper limb in stroke survivors and pave the way for an alternative stroke therapy that uses novel wearable technology in the home setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

age ≥ 18 years
unilateral hemispherical involvement
diagnosis of stroke with onset ≥ three months
hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kongversion score (FTHUE-HK) (Fong et al., 2004) between 3 to 6 (with a maximum score of

no complaint of excessive pain and swelling over the hemiplegic arm
Modified Ashworth scale ≤ 2
Mini-mental State Examination (MMSE) ≥ 19 (Wei et al., 2019)
able to follow verbal instructions and 2-step commands in using the wearable deviceand smartphone.

Exclusion

Exclusion Criteria:

participation in another similar form of experimental study during the same period,
having a history of botulinum toxin injection in the past three months
other significant upper limb impairment, i.e. fixed contractures, frozen shoulder andsevere arthritis
diagnosis which will interfere in the use of the device, i.e. visual impairment,active cardiac issues and palliative treatment
not fully vaccinated from COVID-19 .

Study Design

Sham device

June 01, 2023

March 31, 2024

Connect with a study center

Kenneth FONG
Hong Kong, 000000
Hong Kong
Active - Recruiting

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